CN103118605B - For the method and apparatus entering through the apex of the heart and closing - Google Patents

Abstract

The present invention describes and enters the chambers of the heart method and apparatus to carry out intracardiac surgery for providing through the apex of the heart.This device includes helical needle driver, dilator, straight pin and optional seal wire.After entering the chambers of the heart with straight pin, helical needle driver is used to place spiral seam zygonema in cardiac muscle.After removing needle drivers, advance dilator through prepositioned spiral seam zygonema, thus expanding channel and the stitching thread that surrounds.After performing the operation, prepositioned stitching thread can be closed by the outer end of stitching thread of proximally retracting.

Description

For the method and apparatus entering through the apex of the heart and closing

The cross reference of related application

This application claims be filed on June 26th, 2010 in first provisional application number 61/398,485 and the rights and interests in first provisional application number 61/402,042 being filed on August 23rd, 2010, the complete disclosure of above-mentioned application is incorporated herein by.

Background of invention

1. invention field.Present invention relates in general to medical treatment device and method.More particularly it relates to provide the method and apparatus entering the chambers of the heart through the apex of the heart, it is adapted to assist in the chambers of the heart and carries out various operation, such as cardiac valve replacement, valve repair art, atrial septum kposthesis, aneurysmectomy etc..

Cardiac valve replacement on pulsatile heart is dirty and repairing usually via transvascular approach or carry out through apex of the heart route.This invention particularly focuses on, generally via intercostal incision and place in order to provide the relatively large sleeve pipe of the approach leading to the apex of the heart and to set up the entrance through the apex of the heart.Then use general surgical procedures instrument through sleeve pipe to form the otch entering heart, thus the intervention tool being allowed for cardiac valve replacement, kposthesis or other operations passes through.Purse string suture line is often placed in advance, to promote Guan Bi after the procedure is completed at cutting part.

Need to form relatively large access aperture through generally between the intercostal space the 4th rib and the 5th rib to the demand using general surgical procedures instrument to form the otch by the apical region of heart entrance chambers of the heart.The length of otch is generally 4cm or 5cm, and is very painful for patients at this otch of abdominal part.

Due to these reasons, it is desirable to provide the apparatus and method improved to be simultaneously used for entering heart to carry out penetrating through the apex of the heart and penetrating for completing Guan Bi afterwards at related surgical.Such apparatus and method preferably will need the intercostal incision less than the otch being generally necessary in the past, and especially, if otch is less than 5cm, it is preferable that less than 4cm, and be even more preferably less than 3cm or less, then by satisfactory.Method and apparatus also should provide entrance and the Guan Bi scheme of simplification simultaneously, it should patient constitutes minimum risk, economical and relatively easy during for doctor.At least some target that the following description of the present invention will meet in these targets.

2. background technology.U.S. Patent Publication No. 2011/0015728,2011/0004235 and 2009/0287183 describes for entering the chambers of the heart to carry out the equipment of prosthetic valve replacement and other operations through the apex of the heart.U.S. Patent Publication No. 2010/0268253 describes the self-closing structure can being installed in around apex of the heart entry site.U.S. Patent number 4,204,541 describes the spiral needle for carrying out vertical stitching in including the tissue of heart tissue and living tissue.U.S. Patent number 7,758,595,7,637,918,5,545,148 and 5,356,424 and U.S. Patent Publication No. 2009/275960,2008/275473,2006/253127 and 2006/212048 describe other robotic suturing devices with spiral needle.

Summary of the invention

In a first aspect of the present invention, method for entering the chambers of the heart through the apex of the heart includes advancing spiral needle to dispose stitching thread through cardiac muscle with the apical region of heart via heart, recall spiral needle thus stitching thread being retained in a spiral manner position suitable in cardiac muscle, and in hereafter expanding the passage of the entrance chambers of the heart via spiral seam zygonema.Prepositioned stitching thread then can be used for Guan Bi and leads to the follow-up otch in heart, by simply proximally tractive stitching thread close such otch.Stitching thread is usually from anchoring, such as there is anchoring barb or T-bar at its far-end or close to far-end, and relatively small instrument can be used, be typically inserted through less than 3cm, may often be such that less than 2cm, and intercostal incision less than 1cm completes to place in some cases.The method is also adapted to carry out on pulsatile heart is dirty, but it also can use in the operation stopping heartbeat.In the exemplary embodiment, while advancing spiral needle and/or advancing dilator traverse spiral seam zygonema, pericardium keep tension force with stable heart (being described more fully hereinafter in).

In the illustrative embodiments of the inventive method, first make spiral needle through the pericardium around heart, and then proximally tractive spiral needle to strain pericardium and stable heart.Then spiral needle is pushed cardiac muscle, on pericardium, keeps tension force simultaneously.Except using spiral needle to apply on pericardium except pull strength or alternatively scheme, it is also possible to for such axle or other assemblies of entering tool offer: it is with barb, expansion member or is adapted at advancing simultaneously engaging with pericardium and applying the assembly of pull strength of described pin.

In great majority operation, it will advanced staight needle through the apical region of heart of heart before introducing spiral needle, in order to set up through myocardium initial structure road and confirm correct entrance and orientation.Alternatively, as described in greater detail below, described pin can be used to place seal wire, but pin itself would generally be used as the guide rod disposing device for introducing spiral needle.In this case, pin possibility must have near-end lining, and this lining can remove before pushing through on it by spiral needle assembly.Alternatively, needle shaft can long enough, to allow to be pre-loaded on staight needle by spiral needle assembly entering before the chambers of the heart.

In many cases, the present invention will use single spiral needle, in order to places single spiral seam zygonema.But in other embodiments, it may be desirable to dispose multiple spiral needle, it is common that use same pin deployment shaft simultaneously.In some cases, can coaxial two or more spiral needle nested, one of them spiral needle has small diameter and installs radially inward relative to external spiral pin.In other cases, said two or more spiral needle can be located in common cylindrical envelope.In this case, pin can have multiple tip that penetrates, and the plurality of penetrates most advanced and sophisticated biasing mutually rotating and/or axialy offset.

Stitching thread would generally be placed in cardiac muscle, and it will not be made to extend in the chambers of the heart (beyond cardiac muscle).In this case, being used in its far-end, to have the stitching thread self-deploying barb will be useful especially.When pin is pushed in tissue rotatably, Barb portion ground protrudes the outside of pin.But, once the rotation propelling of spiral needle stops and reversion, barb just will anchor in the tissue, and when spiral needle is reversed rotation and removes from tissue by position for the far-end of stitching thread.But, in other cases, it may be desirable to stitching thread is advanced in the chambers of the heart always.In this case, some other self-deploying anchoring piece, such as T-bar, it will obtains and uses.

The method set up through apex of the heart entrance that is used for according to the present invention will be used along with the various intracardiac surgeries that can carry out on pulsatile heart is dirty.In this type of operation, the passage of the expansion by being formed through cardiac muscle introduces one or more instruments, and spiral seam zygonema retains the appropriate location of around tool when advancing described instrument.This instrument will be used to carry out operation on heart, then after having performed the operation, remove one or more instrument from the passage of expansion.When removing instrument and for, after any device of entering, the passage of expansion can be closed by tractive stitching thread in the proximal direction, thus closing prepositioned spiral suture loop described above.Methods herein is suitable for various intracardiac surgery, including prosthetic valve replacement, valve repair art, left auricle block technique, cardiac ablation art, atrial septal defect block technique, patent foramen ovale percutaneous transcatheter closure etc..

In a second aspect of the present invention, it is provided that for setting up the system entered through the apex of the heart through cardiac muscular tissue.This system includes helical needle driver, and this driver has cylindrical axle, and this axle has far-end, near-end and the central passage extended between described two ends.Spiral needle coupled to the far-end of axle, and stitching thread is carried releasedly by spiral needle.This system also includes having the dilator of the bigger width than cylinder oblique crank Z, and wherein dilator is suitable for exchanging helical needle driver, to expand passage via the spiral seam zygonema being retained in cardiac muscle appropriate position.Generally, dilator will advance along staight needle or alternatively along the seal wire disposed by staight needle.System also optionally includes sheath or the trocar, for setting up from intercostal entry site or the approach leading to pericardium alternatively from entry site xiphoid-process.

In a simpler embodiment, helical needle driver can only include spiral needle (or below in connection with multiple pins that the method for the present invention describes), this pin is fixedly attached to the far-end of cylinder oblique crank Z, in order to advance pin through organizing by rotating whole cylinder oblique crank Z.It is preferable, however, that helical needle driver also will include for the mechanism relative to cylinder oblique crank Z rotating screw pin, in order to advance spiral needle relative to axle itself and to advance it into through tissue.One exemplary driving mechanism is included within its far-end and carries coaxial inner cylindrical or the pipe of one or more spiral needle.Then can such as use the screw drive assembly in the handle of axle assembly, by rotating and propulsion tube countershaft relative to outside axle, and advance pin relative to exterior cylindrical oblique crank Z.

In most of the cases, spiral needle is hollow, and is contained in the hollow channel of pin by stitching thread at least partially along pin length.But, in other cases, it is possible to stitching thread is wound or wrapped around in the outside and/or wire surface of pin in the groove of formation (wherein pin needs not to be hollow).Such as, stitching thread can be wrapped in the external surface peripheral of pin so that stitching thread is retained in cardiac muscle in the way of lax, and wherein when stitching thread is by dilator radial dilatation, suture length more than needed can be used for expanding or extending.

Described system optionally includes other assemblies, such as initially entering the staight needle of the chambers of the heart through cardiac muscle, optionally uses the seal wire that this staight needle is placed, etc..In another case, the cylinder oblique crank Z of pin deployment tool is by along pin and/or along seal wire propelling to set up the initial breakthrough through cardiac muscle.Another option is that being used in its far-end has conduit or other guides of sacculus or other anchoring pieces, wherein after its distal tip is inserted ventricle, it will launch anchoring piece and retraction induced device, providing opposite force thus inserting for dilator.

Accompanying drawing explanation

Fig. 1 illustrates constructed according to the principles of the present invention, and for setting up the system entered through the apex of the heart leading to the chambers of the heart, and this system includes helical needle driver, dilator, staight needle and optional seal wire.

Fig. 2 A and Fig. 2 B illustrate in detail the helical needle driver of Fig. 1, spiral needle of wherein retracting in fig. 2, and advances spiral needle in fig. 2b.

Fig. 3 A and Fig. 3 B correspondingly illustrates the stitching thread anchoring piece with barb and T-bar stitching thread anchoring piece, and they are originated in the far-end of spiral needle.

Fig. 4 A and Fig. 4 B illustrates the crosspointer embodiment of the sharp-pointed needle tip with axialy offset.

Fig. 5 A and Fig. 5 B illustrates the crosspointer embodiment of the sharp-pointed needle tip with biasing 180 °.

Fig. 6 A and Fig. 6 B illustrates the crosspointer embodiment of the internal coiling pin with larger-diameter external spiral pin and small diameter.

Fig. 7 A-Fig. 7 E illustrates the shrink form of exemplary in accordance with the principles of the present invention dilator.

Fig. 8 A-Fig. 8 J illustrate according to the principle of the invention carry out exemplary through the apex of the heart enter operation and get involved.

Detailed description of the invention

With reference to Fig. 1, the system 10 of constructed according to the principles of the present invention includes helical needle driver 12, dilator 14, staight needle 16 and optional seal wire 18.The assembly of system generally will be packaged together in conventional packaging such as such as plastic pallet, sterile bag, box etc..The relative size of each assembly will be selected so that compatible with each other.Such as, the size of helical needle driver 12 and dilator 14 will be suitable for along pin 16 (in the embodiment that pin will be used as to introduce through cardiac muscle the guide rod of these instruments) or advances along seal wire 18 (in the embodiment that will advance driver 12 and dilator 14 along seal wire).

Referring now to Fig. 2 A and Fig. 2 B, helical needle driver 12 comprises axle assembly 20, and this axle assembly 20 has far-end 22 and near-end 24.Driving handle 26 is attached to the near-end 24 of axle assembly 20, and includes internal whorl body 28 (Fig. 2 A) and outer rotatable component 30.Outer rotatable component 30 can rotate on internal whorl body 28, thus correspondingly can like that optionally retract as in figs. 2 a and 2b and advance spiral needle 36.

The internal whorl body 28 of driving handle 26 is securely attached to the external cylindrical pipe 32 of axle assembly 20, and outer rotatable component 30 is attached to inner tubular member 34 (Fig. 2 A).By this way, the outer rotatable component 30 rotation on internal whorl body 28 not only rotates but also advance (or retraction) to be securely attached to the spiral needle 36 of the far-end of inner tubular member 34.Although illustrating with simple spiral needle, but the pin in helical needle driver can have any configuration shown in Fig. 3 A/ Fig. 3 B to Fig. 6 A/ Fig. 6 B described below.

Helical needle driver 12 also includes central canal 38, and this central canal 38 extended the whole length of helical needle driver 12, and as described in greater detail below, provides central passage or inner chamber for driver along the propelling of staight needle 16 and/or seal wire 18.

With reference to Fig. 3 A and Fig. 3 B, it will usually in stitching thread 40 filling or being maintained at the hollow channel of the distal portions at least across pin 36.Stitching thread will stretch out and be installed in duck eye near the sharp tip 44 of pin or aperture 42.Stitching thread will have the anchoring piece formed on its exposed ends place or exposed ends.This anchoring piece can be the structure 48 with barb as shown in fig. 3, T-bar structure 50 as shown in Figure 3 B, or be anchored at in-house other structures multiple when allowing stitching thread to be pushed in tissue and reversely rotate when pin and recall from tissue any.Can configure and/or dispose stitching thread to adapt to expansion when spiral " cage " advancing dilator to be subsequently formed through deployment stitching thread.Such as, stitching thread can be " telescopic " along its length, so that the diameter of spiral cage can advance with dilator and increase.Alternatively, can suture length more than needed be filled in spiral needle and/or on spiral needle, thus provide extra elongation ability when stitching thread is retained in the tissue.

Now with reference to Fig. 4 A/ Fig. 4 B to Fig. 6 A/ Fig. 6 B, the configuration of multiple crosspointer is described.The advantage utilizing two, three or more spiral needle is in that: the stitching thread of greater density can be retained in appropriate location, in order to the tighter Guan Bi of the expanding channel that offer is formed via cardiac muscle and constriction.In Fig. 4 A/ Fig. 4 B, a pair spiral needle 16,62 is nested, so that they are positioned at same cylindrical envelope while correspondingly having distal tip 64 and 66, described distal tip 64 and 66 terminates with axially spaced pattern.As shown in figs. 5 a and 5b, pin 70,72 is also nested, so that they are arranged in same cylindrical envelope, but sharp-pointed distal tip 74,76 correspondingly terminates in the position of relative to each other 180 °.As the 3rd alternative, as shown in Fig. 6 A/ Fig. 6 B, spiral needle 80,82 can being arranged to cylindrical nested arrangement, wherein external helicoid pin 80 has the diameter bigger than internal helicoid pin 82.Sharp-pointed distal tip can become 180 ° of opposition to terminate as shown in Figure, or can terminate (not shown) with axially spaced configuration.

Referring now to Fig. 7 A to Fig. 7 C, dilator 14 preferably comprises the main body at least formed on its distal portions by elastomeric material or other compressible materials.Such as, elastomeric material can form the outer tubular assembly 90 shown in Fig. 7 A, and this outer tubular assembly 90 is formed on internal rigid tubular leg 92.This pipe has inner chamber 93, and this inner chamber 93 is suitable for accommodation and is present in the entrance pin in the initial structure road of expansion and/or seal wire and advances along it.Cutting blade 94 can be attached to the far-end of inner support pipe 92, and such blade can be buried in the protector 96 as shown in Fig. 7 B (as shown in for double blade configuration) and Fig. 7 C (shown in for four blade configuration).In this way, the cutting blade preventing blade 94 is cut unintentionally tissue, but cutting blade will be exposed when leaning on opposing expansion and the tissue tough and tensile especially cut by needs or film (such as pericardium) when dilator tip joint.Alternatively, packer can comprise outer sleeve 93 and removable packer 95 (Fig. 7 D) or can have external screw thread 97 (Fig. 7 E), is advanced through cardiac muscle thus assisting in.

Blade 94 needs the width with the whole diameter crossing over dilator 14.Such as, typical dilator diameters would is that 1cm, and 2mm to 6mm generally will only be crossed over by blade.Alternatively or additionally, dilator can have external screw thread, and this external screw thread allows dilator to rotate to strengthen the propelling through tissue tract around its axle.

Now with reference to Fig. 8 A to Fig. 8 J, describe according to principles of the invention through the apex of the heart entrance chambers of the heart the exemplary arrangement carrying out intracardiac surgery.Illustrate relevant patient anatomy in fig. 8 a, wherein being protected after the rib of patient through apical region of heart TA of patient's heart H.Generally will perform entrance through the intercostal space rib R4 and rib R5.

First, as seen in fig. 8b, staight needle 16 will carry out between rib R4 and R5 intercostal penetrate so that pin sharp tip can through apical region of heart TA enter heart.Generally, staight needle will pass little intercostal incision, and this otch, such as less than 3cm, is typically smaller than 2cm, and usually about 1cm.In order to assist to guide, staight needle is in combinations with ultra sonic imaging or optical imagery.Alternatively, independent otch can be passed through and dispose thoracoscope or other endoscopies to allow visualization.

As seen in fig. 8 c, after advancing pin to enter the left ventricle of heart through cardiac muscle, it will remove Needle sleeve 17 and helical needle driver 12 will be advanced along pin 16.The axle assembly 20 of needle drivers 12 will be advanced, until the distal tip of axle engages the pericardium around the cardiac muscle of heart.

Referring now to Fig. 8 D, spiral needle 36 will advance from the far-end of axle assembly 20 first to penetrate pericardium P.Once pin has penetrated pericardium, helical needle driver 12 just will proximally be retracted thus pericardium is applied tension force, and help is stablized heart and promotes that pin enters heart by this.

As seen in fig. 8e, can pericardium P still in traction under while rotating screw pin 36 and push it into cardiac muscle M.Staight needle 16 is also held in place helping lead screw pin 36.

Preferably, pin 36 will not be fully advanced in left ventricle, and on the contrary, pin rotates and will stop and reversing, in order to as seen in fig. 8f, with intramyocardial barb anchoring piece 48, spiral seam zygonema is retained in appropriate location.Now, helical needle driver will be recalled completely, thus straight (guiding) pin 60 and spiral seam zygonema 40 being retained in position.

It follows that as shown in Fig. 8 G, dilator 14 will be advanced along pin 16, until its distal tip arrives pericardium P.When advancing dilator 14 through pericardium, buried blade 94 will come out because the elastomeric material around them is compressed by pericardium.Blade 94 helps dilator 14 through pericardium, and dilator can enter cardiac muscle M then as shown in Fig. 8 H.Owing to cardiac muscle M is threadiness unlike pericardium and is difficult to penetrate, therefore along with the tip of dilator 14 is pushed into the left ventricle of heart, elastomeric material will recover from compression, and blade 94 will be buried in tip again.Blade 94 is optional, particularly when advancing dilator then particularly true through carrying out pericardium before pericardium cutting in advance.It is not usually required to blade to advance dilator through myocardium.

When dilator 14 is through spiral seam zygonema 40, stitching thread obtains radial dilatation.Generally, it will by spiral needle, the stitching thread of excess length is retained in appropriate location, in order to promote radial dilatation.Such as, can being filled in the central passage of pin with sinuous configuration or closely knit configuration by stitching thread 40, the tension force on stitching thread will extend across its length in the configuration.Additionally optionally, it is possible to provide there is sacculus or the pin of other expandable type anchoring pieces, seal wire or other guide (not shown), thus allow the reverse traction on cardiac muscle when advancing dilator.

As shown in Fig. 8 H, will remove dilator after cardiac muscle M at dilator 40, and as shown in Fig. 8 I, place along pin 16 and there is the working column WC of haemostatic valve HV and pin is removed.Working column provides approach for the Work tool being intended for carrying out desired any specific intracardiac surgery.Illustrate exemplary tool T, it is to be understood that, concrete instrument will be relevant to concrete operation.Alternatively, working column can be a part for dilator, is wherein removed by the central component (packer) of dilator to retain outer sleeve in position as sleeve pipe.

Finally, as shown in figure 8j, after completing intracardiac surgery and removing working column WC and all of instrument T, can proximally retract to close intramyocardial spiral suture loop thus close incisions I by stitching thread 40.By stitching thread ligation, but more generally can will advance along stitching thread and sew up lock 100 to keep suture loop and to prevent otch I from again opening.

Although being the complete description of the preferred embodiment of the present invention above, but also can use various replacement, amendment and equivalents.Therefore, above description should be considered as the restriction to appended claims invention defined scope.

Claims (12)

1., for setting up the system entered through the apex of the heart leading to the chambers of the heart via cardiac muscular tissue, described system includes:

Cylinder oblique crank Z, it has far-end, near-end and the central passage extended between described far-end and described near-end；

Spiral needle, described spiral needle is securely attached to the far-end of described cylinder oblique crank Z, in order to advance described spiral needle through organizing by rotating this axle；

The stitching thread carried releasedly by described spiral needle；And

Dilator, it has the bigger width than described axle, and described dilator is adapted to be along described axle and advances or exchange described axle, with via the described stitching thread being retained in through cardiac muscle appropriate position to expand passage,

Wherein said system also includes axle assembly and driving handle, described axle assembly includes an external cylindrical pipe and has proximally and distally, described cylinder oblique crank Z and described spiral needle are contained in this external cylindrical pipe described spiral needle to be released the far-end of described axle assembly or the far-end of described axle assembly of retracting, described driving handle is attached to the near-end of described axle assembly, and described driving handle includes internal whorl body and outer rotatable component, described outer rotatable component rotates on described internal whorl body；And the described internal whorl body of wherein said driving handle is securely attached to the described external cylindrical pipe of described axle assembly, and this outer rotatable component is attached to described cylinder oblique crank Z so that the rotation on described internal whorl body of the described outer rotatable component had not only rotated but also advanced or the described spiral needle of the described far-end being securely attached to described cylinder oblique crank Z of retracting.

2. the system as claimed in claim 1, also includes sheath, and this sheath for entering pericardium via intercostal entry site on the apical region of heart of heart, and wherein said cylinder oblique crank Z is suitable for advancing via described sheath.

3. the system as claimed in claim 1, also includes the sheath for entering pericardium on the apical region of heart of heart via subxiphoid approach, and wherein said cylinder oblique crank Z is suitable for advancing via described sheath.

4. the system as claimed in claim 1, wherein said spiral needle is hollow, and described stitching thread is contained in described spiral needle.

5. the system as claimed in claim 1, wherein said stitching thread carries barb along distal region, and wherein said barb is suitable for self-deploy to be anchored in cardiac muscular tissue when recalling described spiral needle.

6. the system as claimed in claim 1, wherein said stitching thread carries T-bar, in order to be anchored in the chambers of the heart when recalling described spiral needle.

7. the system as claimed in claim 1, also includes the staight needle for initially entering the chambers of the heart via cardiac muscle.

8. system as claimed in claim 7, wherein said cylinder oblique crank Z and spiral needle are adapted to be along described staight needle and advance.

9. system as claimed in claim 7, wherein said staight needle is suitable for disposing seal wire via cardiac muscle, and described cylinder oblique crank Z and spiral needle are adapted to be along described seal wire and advance.

10. the system as claimed in claim 1, wherein said dilator has threaded outside to promote the propelling via tissue.

11. the system as claimed in claim 1, wherein said dilator comprises outer sleeve and internal packer, and wherein said packer can be removed the appropriate location to be retained in the tissue tract of expansion by described sleeve.

12. system as claimed in claim 11, wherein said sleeve includes haemostatic valve.